Spectranetics Turbo-Elite Laser Atherectomy Catheter 2 — Class II medical device recall Z-0509-2024
Ongoing recall by Spectranetics Corporation, reported 2023-12-20, distributed nationwide. Incorrect product labeling. Exterior product box label does not match internal pouch label.
| Recall number | Z-0509-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2023-12-08 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, IT, PL |
| Quantity | 1,239 catheters |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00813132024727, 00813132024734, 00813132024758, 00813132024765 |
| Lot numbers | FAZ23F06A, FBA23F09A, FBF23F05B, FBH23F02A |
| Model numbers | 414-159, 417-152, 420-006, 420-159 |
Product
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
Reason for recall
Incorrect product labeling. Exterior product box label does not match internal pouch label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0509-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.